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SOLTI Breast Cancer Molecular Screening Program (AGATA) (AGATA)

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ClinicalTrials.gov Identifier: NCT02445482
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
SOLTI Breast Cancer Research Group

Brief Summary:

In recent years, the advance in high-throughput techniques, such as microarrays and next gen sequencing (NGS) technologies, have allowed a more precise classification of the breast cancer molecular subtypes and a more personalized approach to anti-cancer therapy. To date, conventional methods to select patients for clinical trials with anti-targeted agents according to molecular criteria are generally limited to the analysis of a few biomarkers. Recent studies have shown how this strategy is inappropriate in case of infrequent molecular alterations and that the ideal strategy would consist in simultaneous examination of large numbers of actionable genomic alterations.

This is the first genomic screening platform ever attempted in Spain. By this molecular platform SOLTI aims to increase the likelihood of a patient being included in a trial designed specifically for her molecular tumor type. Thus, the primary objective of this pilot study is to determine the Platform's effectiveness to include patients in clinical trials with targeted agents based on the tumor molecular profiling.


Condition or disease Intervention/treatment
Metastatic Breast Cancer Procedure: Biopsy

Detailed Description:

This is a prospective, multicenter, pilot study conducted in eight sites located in Spain. Up to 260 female or male patients, between 18-70 years with advanced or metastatic breast cancer will be screened. These patients will be about to receive, or receiving, or will have received treatment for their disease in either a clinical trial or the healthcare setting. Quality of life score according to ECOG scale ≤ 2 and a minimal life expectancy of 3 months. Upon signed inform consent and confirmation of eligibility criteria, tumor samples will be obtained from the patients either by biopsy of metastatic cancer or from archived tissue previously available at the site, and their genomic profile will be analyzed. It will be assessed the mutational status of a panel of genes considered relevant to the tumor biology and treatment. Detected variants /mutations in samples will not be classified according to their origin somatic or germline, since no normal paired DNA will be analyzed. Should any clinical trial match the patient's molecular profile, she/he will be offered to participate in it and the available samples left after sequencing will be supplied when a central confirmation would be requested. The patient's clinical data will be collected on a quarterly basis until death or consent withdrawal.

Mutation testing will be carried out at three laboratories experienced in high-throughput sequencing techniques: the VHIO Cancer Genomics Core laboratory of Barcelona, at Genomics Laboratory of the Research Institute of the Doce de Octubre University Hospital of Madrid and at the Genomics laboratory of the University Clinical Hospital of Valencia. There is a need to join efforts, set standards and optimize procedures for the benefit of all patients, so that the opportunity to participate in a genomic screening program can be offered to the great majority of hospitals that lack the technology required for these tests.


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Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SOLTI Molecular Screening Program: a Pilot Study to Implement Personalized Therapy for Patients With Advanced or Metastatic Breast Cancer
Actual Study Start Date : October 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Procedure: Biopsy
    archival tissue or fresh biospsy


Primary Outcome Measures :
  1. Platform's effectiveness mesured as the proportion of patients included in clinical trials with targeted agents based on the tumor molecular profiling [ Time Frame: 30 months ]

Secondary Outcome Measures :
  1. Characterization of the genomic profiles of the breast cancer patients included in the program listing the percentage of mutations deemed potentially actionable [ Time Frame: 30 months ]
  2. List of the potential barriers of the program [ Time Frame: 30 months ]
  3. Comparison of the percentage of patients included in clinical trials according to their genomic profile between the different panels and sequencing methods. [ Time Frame: 30 months ]
  4. Percentage of the patients alive and without progression (PFS) and percentage of patients alive (OS) of the patients receiving any targeted therapy based on molecular profiling [ Time Frame: 30 months ]
  5. Comparison of the PFS and OS percentages of patients included in clinical trials according to the genomic profile of their tumor with those of patients not assigned to these clinical trials [ Time Frame: 30 motnhs ]

Biospecimen Retention:   Samples With DNA
Collection of the archived initial or metastatic tumor sample (one 60 μm formalin-fixed, paraffin-embedded tumor block). If archived material is not available, a biopsy of the metastatic cancer should be performed to obtain such material


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will be conducted in eight sites located in Spain, and up to 260 patients with advanced or metastatic breast cancer will be screened. These patients will be about to receive, or receiving, or will have received treatment for their disease in either a clinical trial or the healthcare setting
Criteria

Inclusion Criteria:

  • Female or Male patients
  • Between 18 and 70 years of age
  • Signed informed consent prior to any screening procedure
  • Advanced or Metastatic breast cancer of any subtype confirmed both pathologically and radiologically (stage IIIb- IV disease)
  • The patient may present with a responding, stable or progressive disease
  • The subjects must be about to receive, or receiving, or will have completed treatment for their metastatic disease with any line of treatment in either a clinical trial or the healthcare setting
  • Availability of one archived initial or metastatic tumor sample. If archived material were not available, a biopsy of the metastatic cancer should be performed to obtain such material.
  • Measurable or non-measurable disease
  • Quality of life score according to ECOG scale ≤ 2
  • Minimal life expectancy of 3 months

Exclusion Criteria:

  • Presence of progressive disease at the time of inclusion requiring treatment initiation before genomic profile results are obtained
  • LVEF<50% (MUGA)
  • Inadequate bone marrow reserve or organ dysfunction shown by any of the following laboratory values:
  • Absolute neutrophil count
  • Platelet count< 100 x 109/L
  • Hemoglobin < 90 g/dL
  • AST/ALT > 2.5 times the upper limit of normality if no demonstrable hepatic metastases, or > 5 times the upper limit of normality in the presence of hepatic metastases
  • Total bilirubin > 1.5 times the upper limit of normality
  • Creatinine>1.5 times the upper limit of normal
  • Corrected calcium > upper limit of normality
  • Phosphate > upper limit of normality
  • Presence of any other type of cancer, except suitably

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02445482


Locations
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Spain
Institut Català d' Oncologia
Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Islas Baleares, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d' Hebrón
Barcelona, Spain
Institut Català d' Oncologia de Girona
Girona, Spain
Complejo Integral Oncologico Clara Campal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen del Rocio
Sevilla, Spain
Hoapital Universitario Arnau de Vilanova
Valencia, Spain
Hospital Universitario Clinic de Valencia
Valencia, Spain
Sponsors and Collaborators
SOLTI Breast Cancer Research Group
Investigators
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Principal Investigator: Eva Ciruelos, MD SOLTI Breast Cancer Research Group
Principal Investigator: Sonia Pernas, MD SOLTI Breast Cancer Research Group

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Responsible Party: SOLTI Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT02445482     History of Changes
Other Study ID Numbers: SOLTI-1301
First Posted: May 15, 2015    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases